Abstract
This paper focuses on international standards and guidelines related to evaluating the safety and performance of wearable dialysis systems and devices. The applicable standard and evaluation indices for safety and performance are determined, and the relevant international standards and guidelines are provided in a table. In addition, example experiments using a triaxial accelerometer and robot arm are presented for testing the endurance and safety of wearable artificial kidneys. The findings in this paper can be used to suggest new guidelines for the mechanical safety and performance evaluation of wearable artificial kidney systems.
Highlights
As lifestyle-related metabolic disorders such as diabetes and hypertension continue to proliferate with westernized diets, the number of patients with end-stage kidney failure has drastically increased
The surveyed standards and guidelines were used to derive safety and performance evaluation indices that seem applicable to wearable artificial kidneys
Along with the evaluation methods specified by existing standards, example methods for evaluating the durability and safety are presented
Summary
As lifestyle-related metabolic disorders such as diabetes and hypertension continue to proliferate with westernized diets, the number of patients with end-stage kidney failure has drastically increased. When end-stage kidney failure is caused by diabetes, which is most frequently the case, the 5-year survival rate is only 50%–60%. This is much lower than the rates for stomach cancer and colorectal cancer. About 11% of patients treated with peritoneal dialysis and 0.6% of those treated with hemolysis have been reported to stay at home for therapy. This indicates the rapid growth and increasing use of home-use self-dialysis units [1], [2]. A safety and performance evaluation method is proposed for new types of wearable artificial kidneys
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